Topics Map > Research Policy and Compliance > Human Research Protection Program (HRPP) > HRPP Policies

Exceptions to Informed Consent Requirements in Emergency Situations

The document describes when the UW-Madison IRBs make exceptions to the informed consent requirements in emergency situations.

  1. UW-Madison IRBs may allow exceptions to the informed consent requirements for emergency use of test articles in conformance with FDA regulations and guidance [21 CFR 50.23]. See, Emergency Use of Test Articles Policy.

  2. UW-Madison IRBs may waive the requirement to obtain informed consent for planned emergency research in conformance with the federal Common Rule [45 CFR 46] and FDA regulations [21 CFR 50.24] and guidance. See, OHRP Emergency Research Informed Consent Requirements; FDA IRB Information Sheets - Updated 9/98.

Adopted By: All Campus IRB
Adoption Date: November 10, 2005
Revised By: Cross-Campus HRPP Advisory Committee
Revision Date: November 7, 2019

Copyright © 2006 University of Wisconsin System Board of Regents

Keywords:emergency use planned consent waive exceptions   Doc ID:29562
Owner:Travis D.Group:VCRGE and Graduate School
Created:2013-04-18 12:06 CDTUpdated:2019-11-12 16:30 CDT
Sites:VCRGE and Graduate School
Feedback:  0   0